OBI-992 TROP2 ADC has been granted by US FDA to proceed to Phase I/II human clinical trial

1.Date of occurrence of the event:2024/01/03
2.New drug name or code: OBI-992 TROP2 ADC
OBI-992 is an antibody drug conjugate (ADC) for cancer treatment that is based on TROP2 to target cancer cells. ADC releases a small molecule payload
through the specificity of the antibody and directly deploys cytotoxic molecule at the targeted cancer cells. Antibody that is linked with a
payload binds to the targets on tumor cells followed by entering into cells via internalization. The small molecule payload will then be released through
enzymatic cleavage to achieve the goal of killing tumor.
4.Planned development stages: Phase I, II, III clinical trial, and Biologics License Application (BLA)
5.Current development stage:
(1)Application submission/approval/disapproval/each of clinical trials (include interim analysis): OBI-992 TROP2 ADC has been granted by US FDA
to proceed to Phase I/II human clinical trial.
(2)Once disapproved by competent authority or each of clinical trials (include interim analysis) results less than statistically significant
sense, the risks & the associated measures the Company may occur: Not applicable
(3)After obtaining official approval or the results of statistically significant sense, the future strategy: Proceed to Phase I/II human clinical trial
(4)Accumulated investment expenditure incurred: For negotiation on potential licensing deals in the future, and for the best interest of shareholders,
this information is kept confidential temporarily.
6.Upcoming development plan: Phase I/II clinical trial – Phase I Dose Escalation
(1)Estimated date of completion: 2025Q2
(2)Estimated responsibilities: The Company is responsible for clinical trial related expenses, including development milestones to be paid to Biosion,
Inc. under the terms of the license agreement.
7.Market situation:
According to GlobalData, the global market for ADC therapies in oncology is projected to be US$ 9.7 billion in 2023 and is expected to reach over US$ 36
billion by 2029, growing at a compound annual growth rate (CAGR) of 24.5%. While OBI-992 is intended to target unmet medical needs where a meaningful
clinical benefit to the patients is identified, advancement of OBI-992 in further studies will be determined eventually as part of the development
strategy for the entire OBI pipeline.
8.Any other matters that need to be specified(the information disclosure also meets the requirements of Article 7, subparagraph 8
of the Securities and Exchange Act Enforcement Rules, which brings forth a significant impact on shareholders rights or the price of
the securities on public companies.):None.
9.New drug development requires long process, vast investments and with no guarantee in success which may pose investment risks. The investors
are advised to exercise caution and conduct thorough evaluation.